Sr. QMS Specialist

Company Description

Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We’re a fast-growing dynamic organization and we seek an experienced Manufacturing Technician to help us with our growth.  

At Sirtex, we’re transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do. We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions. 

Our facility in Wilmington, MA is responsible for the manufacturing of time sensitive high-energy beta radiation to support the treatment of inoperable liver tumors.  We are looking for a high energy, self-motivated, team player, with a passion for making a difference to join our diverse team.

Job Description

Primary focus of this role is to ensure a compliant, effective, and efficient Quality Management System which meets Sirtex business needs and appliable regulations.

This role will report to the Executive Vice President of Quality Assurance and be located at the Woburn, MA Sirtex facility or US remote with working hours within one hour of Woburn. Applicants should live in the Eastern and Central time zones. 

• Develop, implement, monitor, and improve the Sirtex Quality Management System related procedures, tools, training, metrics, etc.
• Support activities resulting in a QMS which is compliant, effective, and efficient which meets Sirtex business needs and appliable regulations
• Facilitate processes such as CAPA, internal audit program, Management Review, periodic Quality Review, and other processes as identified by manager
• Develop and monitor KPIs across the QMS, escalating issues via established processes
• Support and participate in internal and external audits
• Support ad hoc requests as part of Sirtex Quality Team
• Complete all training required by role
• Observe and Comply with all Sirtex Corporate Policies
• Comply with Sirtex Quality Management System

Qualifications

• Minimum of 5 years Quality Assurance experience within the Medical Device industry with companies having greater than $1bn USD annual revenue
• Bachelor’s Degree
• Demonstrable competency of Medical Device Regulation such as; 21 CFR, 820, EN ISO 13485
• Demonstrated competency in developing and implementing QMS procedures within the medical device industry which are compliant, effective, and efficient
• Demonstrated competency in developing and monitoring QMS related KPIs
• Demonstrated competency in CAPA, internal/external audits, Management Review
• Strong communication and presentation skills.
• Competent in Microsoft Office Suite.
• Familiarity with the EU MDR regulation
• Ability to prioritize, focus, collaborate, and work effectively in a fast paced and dynamic cross-functional environment

Additional Information

All your information will be kept confidential according to EEO guidelines.

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people’s lives.  Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success. 

Sirtex offers qualified candidates:

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical, robust and equitable.
• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.  

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and